BEUDAMED
    FDA Recall Terminated

    Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780

    Recall: Z-0293-2008 · Initiated October 1, 2007

    Recall

    Recall Number
    Z-0293-2008
    Event Number
    45567
    Firm
    Toshiba American Med Sys Inc
    FEI Number
    2020563
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 1, 2007
    Posted
    November 27, 2007
    Terminated
    April 5, 2012
    Address
    2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068

    Description

    Toshiba-Interventional Angiography System, Infinix i, Model DFP-8000D, equiped with Digital Radiography System with Software version 3.4er000, Toshiba America Medical Systems, Inc., Tustine, CA 92780

    Reason

    System Lock-up: When performing DAS One Shot, the system may lockup due to a software timing error.

    Action

    Notification letters (Urgent: Medical Device Correction-dated October 1, 2007) with an attached Customer Response form were sent to customers beginning on October 2, 2007. Customers were notified this action was being taken as a result of an investigation that resulted from a software issue that was found done by the manufacturer. Customers were informed that a Toshiba Customer Service Engineer would contact them to schedule a software upgrade when the software becomes available. If customers have any questions they were instructed to contact their or call (800) 421-1968 and ask for the Regulatory Affairs Department.

    Distribution

    Nationwide-including states of AL, AR, FL, GA, MI, NY, OH, PA, TX & WV

    Quantity

    23